October p. 01. GCP Update Data Integrity

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3 p. 03 failures by organizations to: apply robust systems that inhibit data risks, improve the detection of situations where data reliability may be compromised, and/or investigate and address root causes when failures do arise.

4 p. 04 Good Data and Record Management Practices (GDRP): The totality of organized measures that should be in place to collectively and individually ensure that data and records are secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate and that, if not robustly implemented, can impact on data reliability and completeness and undermine the robustness of decision-making based upon those data records. WHO Technical Report Series No. 996, 2016

5 p. 05 A Quality Risk Management (QRM) approach that effectively assures patient safety and product quality and validity of data by ensuring that management aligns expectations with actual process capabilities Monitoring of processes and allocation of the necessary resources by management to ensure and enhance infrastructure, as required (for example, to continuously improve processes and methods) Adoption of a quality culture within the company that encourages personnel to be transparent about failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and meet data quality standards Mapping of data processes and application of modern QRM and sound scientific principles throughout the data life cycle Ensuring that all site personnel are kept up to date about the application of good documentation practices (GDocP) to ensure that the GXP principles of ALCOA are understood and applied to electronic data

6 p. 06 Data Management Governance: A robust and sustainable good data management system requires data management governance, including: application of modern QRM principles and good data management principles that assure the validity, completeness and reliability of data; application of appropriate quality metrics; assurance that personnel are not subject to commercial, political, financial and other pressures or incentives that may adversely affect the quality and integrity of their work; allocation of adequate human and technical resources such that the workload, work hours and pressures on those responsible for data generation and record keeping do not increase errors;

7 p. 07 Quality culture maintain a working environment that minimizes the risk of noncompliant records and erroneous records and data. transparent and open reporting of deviations, errors, omissions and aberrant results at all levels of the organization. Steps should be taken to prevent, and to detect and correct weaknesses in systems and procedures that may lead to data errors so as to continually improve the robustness of scientific decision-making within the organization.

8 Data Lifecycle p. 08 data generation and capture data disposal data transmission data retention and retrieval data processing data reporting data review

9 p. 09 Data life cycle Validation should include assessing risk and developing quality risk mitigation strategies, including controls to prevent and detect risks throughout the data life cycle. determining the risk-based approach to reviewing electronic data and audit trails based upon process understanding and knowledge of potential impact on products and patients; writing SOPs defining review of original electronic records and including meaningful metadata such as audit trails and review of any associated printouts or PDF records; documenting the system architecture and data flow, including the flow of electronic data and all associated metadata, from the point of creation through archival and retrieval; ensuring that the relationships between data and metadata are maintained intact throughout the data life cycle.

10 audit trails p. 010 Data entries, such as source data for inclusion of a patient in a clinical trial, should be verified by a second person or entered through technical means such as barcoding, as appropriate for the intended use of these data. Additional controls may include locking critical data entries after the data are verified and review of audit trails for critical data to detect if they have been altered.

11 audit trails p. 011 Changes to scientific data may sometimes be most readily viewed by; running various database queries or viewing metadata fields labelled history files or review of designed and validated system reports, The files designated by the software developer as audit trails alone may be of limited value for an effective review. The risk-based review of electronic data and metadata, such as audit trails, requires an understanding of the system and the scientific process governing the data life cycle so that the meaningful metadata are subject to review, regardless of the naming conventions used by the software developer.

12 p. 012 True copies of electronic records should preserve the dynamic format of the original electronic data as this is essential to preserving the meaning of the original electronic data, e.g: preserving the dynamic format of clinical study data captured in an ecrf system allows searching and querying of data, whereas a pdf of the ecrf data, even if it includes a PDF of audit trails, would lose this aspect of the content and meaning of the original ecrf data. Clinical investigators should have access to original records throughout the study and records retention period in a manner that preserves the full content and meaning of the source information. Especially for data that support critical decision-making, even if PDF/printed summaries are maintained, the complete copies of electronic data should continue to be maintained throughout the records retention period to allow for investigations that may be necessary under unexpected circumstances, such as application integrity investigations.

13 p. 013 How can data risk be assessed? Data risk assessment should consider the vulnerability of data to involuntary or deliberate amendment, deletion or recreation. Factors to consider include: Complexity Consistency - degree of automation /human interface Subjectivity of outcome / result Manual interfaces with IT systems can the user influence the reporting of data from the validated system

14 p. 014 How can data criticality be assessed? Points to consider regarding data criticality include: What decision does the data influence? For example: when making a batch release decision, data which determines compliance with critical quality attributes is of greater importance than warehouse cleaning records. What is the impact of the data to product quality or safety? For example: for an oral tablet, active substance assay data is of greater impact to product quality and safety than tablet dimensions data.

15 p. 015 WHO Expert Committee on Specifications for Pharmaceutical Preparations, Annex 5 Guidance on good data and record management practices df EMA GMP/GDP Q&A, : a_detail_ jsp PIC/S draft guidance GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS _on_data_integrity_2.pdf

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